Boston Scientific Recalls Chariot Guiding Sheath Over Safety Concerns

Boston Scientific Recalls Chariot Guiding Sheath Over Safety Concerns
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December 11, 2015

Reports of shaft separation in medical devices is causing concerns for Boston Scientific.

After receiving 14 complaints, the manufacturer is issuing a global recall for its Chariot Guiding Sheath, devices intended for the introduction of interventional devices during peripheral vascular procedures. Of the fourteen complaints for shaft separation, four have involved separation of the distal shaft.

The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs.

To date, no permanent injuries or patient deaths have been reported.

All healthcare facilities and physicians have been advised to discontinue use of these items. Additionally, physicians are encouraged to contact all patients who have undergone procedures involving Chariot to confirm their post-procedure status, as device shaft separation and embolized fragments may not have been recognized at the time of the procedure.

For a list of the specific codes of affected Chariot Guiding Sheaths, see the Food and Drug Administration (FDA) release.

Consumers or healthcare facilities with questions about the recall or the return process can contact Boston Scientific at (800) 811-3211.